Comparing Dry Needling to Manual Therapy for Patients With Mechanical Low Back Pain



Status:Completed
Conditions:Back Pain, Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 70
Updated:9/19/2018
Start Date:December 2014
End Date:August 2018

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Randomized Controlled Trial Comparing the Use of Dry Needling to Manual Therapy for Patients With Mechanical Low Back Pain.

This is a comparative study to determine if there is a difference in pain reduction and
disability between dry needling and manual therapy for patients with low back pain. Subjects
will be seen two times per week for 3 weeks (6 visits) and will receive either dry needling
or manual mobilizations along with patient education and a home exercise program.

Procedures:

Subjects will sign the informed consent prior to any examination procedures. Eligibility
assessment will be performed by the treating physical therapist and will include the subject
filling out the demographic / health history questionnaire, outcome measures, and a clinical
examination. The treating physical therapist will use 2 components of the examination for
eligibility criteria into the study. The treating therapist will press on the subject's
joints in their back to try to elicit their chief complaint. The treating physical therapist
will also press on the soft tissue of the subject's back to check for any symptomatic points.
A symptomatic point would include recreation of their chief complaint, tenderness,
hypersensitivity, or referred pain. The treating physical therapist will then draw an X on
the patient's back where the most symptomatic tissue exists. This point will be used by the
data collecting physical therapist in order to collect pain pressure threshold of the area.

The data collecting physical therapist will have the subject complete an Oswestry Disability
Index(ODI), gather a measure of the pain from the patient ,and the pain pressure threshold.
Each subject will then be allocated to either the manual therapy group or the dry needling
group.

Once a subject is assigned to a group, they will receive either dry needling or manual
therapy mobilizations by the treating therapist. Each subject will remain in the assigned
group as long as they are continuing in the study up to 3 weeks. In addition to the
treatments under investigation, a standardized home exercise program will be assigned to each
of the subjects by the treating physical therapist. This program will be given to and
reviewed with each subject to ensure they understand the exercises and will perform the
exercise program 1x/day for the duration they are under the care of the physical therapist
for the study. Subjects will be treated on day 1 of their plan of care and subsequent
treatments will occur 2x/week for a total of 3 weeks, unless discharge occurs earlier than
the 3 week data point. Early discharge will occur if the subject achieves resolution of
symptoms or if they decide they no longer wish to be a research participant.

Subsequent sessions will involve the collection of outcome data by the data-collecting
therapist followed by treatment performed by the treating physical therapist. No adjustments
will be made to the treatment protocol in any of the sessions. Subjects will only be
scheduled with and treated by the same treating physical therapist each session. In the event
that a treating physical therapist is unable to see a subject participating in the study, the
subject will be rescheduled for a different time to receive care.

Inclusion Criteria:

- There will be 72 subjects participating in this study that present with mechanical low
back pain, ranging from 18-70 years old. The 72 subjects includes a 20% attrition rate
12 additional subjects. The total needed for analysis is 60 subjects, 30 per group.

Exclusion Criteria:

- Subjects will be excluded if the examining therapist cannot provoke either active or
latent MTrPs of the subject's low back muscles and/or elicit symptoms with manual
passive movement of the spine at the joints of the low back. Exclusion criteria will
also consist of the presence of any red flags revealed in the patient history (i.e.,
tumor, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, prior
lumbar surgery, current pregnancy, etc.) or examination (i.e. signs consistent with
significant nerve root compression). Subjects will be excluded if they demonstrate
signs of Chronic Regional Pain Syndrome (CRPS), are currently seeking litigation, are
unable to speak English, and/or have been diagnosed with a condition that can cause
prolonged MTrPs such as fibromyalgia, hypothyroidism, or iron deficiency. In addition,
no patients who have a transmittable blood disease will be included.
We found this trial at
1
site
Youngstown, Ohio 44555
Phone: 330-701-5353
?
mi
from
Youngstown, OH
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